INHANCE 5500-32-104Recalls & reported problems
Depuy (Ireland) · INHANCE SHOULDER SYSTEM REVERSE LINER RETENTIVE X-LINKED VITAMIN E PE Ø32+4mm · Class 2 · Implant
All models of INHANCE (202)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 6
- Deaths reported
- 0
- Injuries reported
- 6
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10603295546764), received between Sep 12, 2024 and Jan 27, 2026 — classified as 6 injuries.
The most frequently reported specific device problem is “Device Dislodged or Dislocated” (3 reports).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem3
- Device Dislodged or Dislocated3
Patient problems
- Joint Dislocation3
- Joint Laxity2
- Unspecified Infection1
Recent adverse event reports
The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.
InjuryJan 27, 2026Adverse Event Without Identified Device or Use Problem
PATIENT WAS REVISED DUE TO INSTABILITY. DOI: (B)(6) 2025, DOR: (B)(6) 2026, AFFECTED SIDE: LEFT SHOULDER.
Patient problems: Joint Laxity
MAUDE report 24189938 ↗InjuryNov 14, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated
IT WAS REPORTED THAT THE PATIENT WAS DISLOCATED. ALL INHANCE COMPONENTS WERE PULLED. DOI: ON (B)(6) 2025, DOR: ON (B)(6) 2025, AFFECTED SIDE: RIGHT SHOULDER.
Patient problems: Joint Dislocation
MAUDE report 23556718 ↗InjuryAug 19, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated
IT WAS REPORTED THAT THE PATIENT'S ORIGINAL SURGERY DATE WAS (B)(6) 2025. PATIENT WAS NON-COMPLIANT. SURGEON WAS REMOVING ITS SLING BEFORE RELEASED TO DO SO, AND DISLOCATED. DUE TO THIS THE SURGEON BROUGHT THE PATIENT BACK FOR A REVISION TO INCREASE THE SIZE OF THE GLENOSPHERE. THE REVERSE SHELL, AND POLY LINER WERE REMOVED TO GAIN ACCESS TO THE GLENOID. THE 32+8 WAS REMOVED AND REPLACED WITH A 36+8. THERE WERE NO ALLEGATIONS MADE AGAINST THE PRODUCT, AND THE CASE WENT WITHOUT INCIDENT. AFFECTED SIDE: UNKNOWN SHOULDER.
Patient problems: Joint Dislocation
MAUDE report 22841869 ↗InjuryJan 28, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE PATIENT WAS REVISED FOR POSSIBLE INFECTION. LINER AND SHELL REMOVED AND REPLACED. THE SURGICAL DELAY IS UNKNOWN. THERE WAS NO SURGICAL DELAY AND ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. NO FURTHER INFORMATION WAS PROVIDED. DOI: (B)(6) 2024. DOR: (B)(6) 2025. AFFECTED SIDE: LEFT SHOULDER.
Patient problems: Unspecified Infection
MAUDE report 21258220 ↗InjuryJan 16, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated
IT WAS REPORTED THAT THE PATIENT HAD DISLOCATED THEIR SHOULDER, AND SURGEON WANTED TO PUT MORE LENGTH INTO THE CONSTRUCT. SURGICAL DELAY WAS UNKNOWN. DOI: UNKNOWN. DOR: (B)(6) 2025. AFFECTED SIDE: LEFT SHOULDER.
Patient problems: Joint Dislocation
MAUDE report 21168158 ↗InjurySep 12, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE DEVICE WAS REPORTED FOR AN UNKNOWN REASON/MALFUNCTION. SURGICAL DELAY WAS UNKNOWN. DOE: (B)(6) 2024. AFFECTED SIDE: LEFT SHOULDER. ADDITIONAL EVENT INFORMATION: THE PATIENT'S SOFT TISSUE STRUCTURES WERE LOOSE AND THEREFORE THE SURGEON NEEDED TO REVISE TO LARGER COMPONENTS. THERE WAS NO SURGICAL DELAY NOR ANY HARM TO THE PATIENT.
Patient problems: Joint Laxity
MAUDE report 20202971 ↗
Other PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED devices
- Equinoxe 320-42-00Exactech, Inc. · Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented3 recalls107 reports
- Equinoxe 320-38-00Exactech, Inc. · Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented3 recalls107 reports
- Equinoxe 320-42-03Exactech, Inc. · Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented2 recalls87 reports
- Equinoxe 320-38-03Exactech, Inc. · Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented2 recalls43 reports
- Equinoxe 320-42-13Exactech, Inc. · Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented2 recalls41 reports
- Equinoxe 320-10-00Exactech, Inc. · Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented132 reports
- Equinoxe 320-36-00Exactech, Inc. · Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented2 recalls27 reports
- Equinoxe 320-42-10Exactech, Inc. · Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented2 recalls14 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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